Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists

Quality of Life Clinical Trial

Official title:

Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597607
• Other study ID #: HREB 6946
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: April 5, 2022

Study information

• Verified date: April 2022
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to look at the efficacy and impact of a pharmacist-led smoking cessation program. It will assess an intensive program and an abbreviated program, with the latter being evaluated for feasibility in community pharmacies. Participants will be in one of two groups: intensive or abbreviated. Smoking abstinence rates, self-efficacy and overall satisfaction will be compared. Additionally, a cost-effectiveness analysis will be executed to determine the feasibility of customized smoking cessation programs in community pharmacies across Newfoundland and Labrador.

Description:

One in five deaths in Canada is linked to smoking. It kills up to 50% of its users and over 7 million people each year. Smoking is also a risk factor for several harmful health consequences that affect the quality of life of those who smoke. It also results in substantial economic costs to society.

Newfoundland and Labrador (NL) has the highest smoking prevalence of Canadian provinces; approximately 18.5% of Newfoundlanders smoke on a daily or occasional basis compared to the national average of 13.0%. The Conference Board of Canada reported this year that smoking costs the local NL economy approximately $135 million per year in direct healthcare costs and $53 million in indirect costs, for a total of $188 million.

According to the CAN-ADAPTT Smoking Cessation Clinical Practice Guideline, several intensive counseling interventions are the most effective for smoking cessation. Offering a combination of counseling and pharmacotherapy increases the likelihood that a person will try to quit by 40-60%. Using this evidence, Memorial University's School of Pharmacy recently established a smoking cessation program at the Medication Therapy Services (MTS) Clinic. The program involves in-depth pharmacist consultation, which includes pharmacotherapy and multiple follow-up counseling sessions.

The investigators propose to test the effectiveness of an intensive and abbreviated smoking cessation program (SCP) delivered by trained pharmacists at the MTS Clinic. They hope that findings from this study will inform stakeholders of the value of the program and of the pharmacists' role. If the program is determined to be effective it could be instrumental in applying smoking cessation programs in community pharmacies across the province, including rural and remote locations.

To date there are only a small number of studies that use the randomized, controlled trial design to evaluate the effectiveness of pharmacist delivered interventions. In addition, data is lacking on the perspective of and satisfaction with smoking cessation services from the eyes of someone who participates in the program. Therefore, this study proposes to execute a randomized control trial to determine the effectiveness of a pharmacist-led smoking cessation program. Cost-effectiveness and a qualitative assessment of participant's journey to quit smoking will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 5, 2022
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults including anyone 19 or older who wish to make a change in their smoking.

Exclusion Criteria:

• People who do not smoke

Related Conditions & MeSH terms

• Quality of Life
• Smoking Cessation
• Smoking, Tobacco

Intervention

Behavioral:
• Intensive Smoking Cessation Group
This group will meet with the pharmacist more frequently and for longer periods than other groups.
• Abbreviated Smoking Cessation Group
This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.

Locations

Country	Name	City	State
Canada	School of Pharmacy	St. John's	Newfoundland and Labrador

Sponsors (1)

Lead Sponsor	Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

References & Publications (26)

Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. 2012 Jun;107(6):1066-73. doi: 10.1111/j.1360-0443.2011.03770.x. Epub 2012 Feb 28. Review. — View Citation

Bock BC, Hudmon KS, Christian J, Graham AL, Bock FR. A tailored intervention to support pharmacy-based counseling for smoking cessation. Nicotine Tob Res. 2010 Mar;12(3):217-25. doi: 10.1093/ntr/ntp197. Epub 2010 Jan 25. — View Citation

Brown TJ, Todd A, O'Malley C, Moore HJ, Husband AK, Bambra C, Kasim A, Sniehotta FF, Steed L, Smith S, Nield L, Summerbell CD. Community pharmacy-delivered interventions for public health priorities: a systematic review of interventions for alcohol reduction, smoking cessation and weight management, including meta-analysis for smoking cessation. BMJ Open. 2016 Feb 29;6(2):e009828. doi: 10.1136/bmjopen-2015-009828. Review. — View Citation

CAN-ADAPTT. (2011). Canadian Smoking Cessation Clinical Practice Guideline. Toronto, Canada: Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment, Centre for Addiction and Mental Health.

Canadian Pharmacists Association. Joint Statement on Smoking Cessation - Tobacco: the Role of Health Professionals in Smoking Cessation. https://www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/PPSmokingCessation.pdf

Canadian Pharmacists Association. Professional Development-QUIT program. https://www.pharmacists.ca/education-practice-resources/professional-development/quit/

Crealey GE, McElnay JC, Maguire TA, O'Neill C. Costs and effects associated with a community pharmacy-based smoking-cessation programme. Pharmacoeconomics. 1998 Sep;14(3):323-33. — View Citation

Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother. 2009 Feb;43(2):194-201. doi: 10.1345/aph.1L556. Epub 2009 Feb 3. — View Citation

Dobrescu, Bhandari, Sutherland and Dinh (2017). The Costs of Tobacco Use in Canada, 2012. The Conference Board of Canada. Retrieved from http://www.conferenceboard.ca/e-library/abstract.aspx?did=9185

Fai SC, Yen GK, Malik N. Quit rates at 6 months in a pharmacist-led smoking cessation service in Malaysia. Can Pharm J (Ott). 2016 Sep;149(5):303-312. Epub 2016 Aug 9. — View Citation

Gagnon-Arpin, Isabelle, Alexandru Dobrescu, Greg Sutherland, Carole Stonebridge, and Thy Dinh. The Value of Expanded Pharmacy Services in Canada. Ottawa: The Conference Board of Canada, 2017.

Government of Newfoundland and Labrador. (2017). The way forward: Realizing our potential. Retrieved from http://thewayforward.gov.nl.ca/documents/Realizing_our_potential.pdf

Kennedy DT, Giles JT, Chang ZG, Small RE, Edwards JH. Results of a smoking cessation clinic in community pharmacy practice. J Am Pharm Assoc (Wash). 2002 Jan-Feb;42(1):51-6. — View Citation

Locke, Wade. (2017). State of N.L. Economy: From Bad to Worse. Presentation by Department of Economics, Memorial University.

Maguire TA, McElnay JC, Drummond A. A randomized controlled trial of a smoking cessation intervention based in community pharmacies. Addiction. 2001 Feb;96(2):325-31. — View Citation

McGhan WF, Smith MD. Pharmacoeconomic analysis of smoking-cessation interventions. Am J Health Syst Pharm. 1996 Jan 1;53(1):45-52. — View Citation

National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. — View Citation

Newfoundland and Labrador Pharmacy Board. Prescribing by Pharmacists Standards of Pharmacy Practice. http://www.nlpb.ca/media/SOPP-Prescribing-by-Pharmacists-Aug2015-revFeb2016.pdf

Reid JL, Hammond D, Rynard VL, Madill CL, Burkhalter R. Tobacco Use in Canada: Patterns and Trends, 2017 Edition. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.

Saba M, Diep J, Saini B, Dhippayom T. Meta-analysis of the effectiveness of smoking cessation interventions in community pharmacy. J Clin Pharm Ther. 2014 Jun;39(3):240-7. doi: 10.1111/jcpt.12131. Epub 2014 Jan 13. — View Citation

Smith MD, McGhan WF, Lauger G. Pharmacist counseling and outcomes of smoking cessation. Am Pharm. 1995 Aug;NS35(8):20-9; 32. — View Citation

Thavorn K, Chaiyakunapruk N. A cost-effectiveness analysis of a community pharmacist-based smoking cessation programme in Thailand. Tob Control. 2008 Jun;17(3):177-82. doi: 10.1136/tc.2007.022368. Epub 2008 Feb 19. — View Citation

The World Health Organization: Tobacco (http://www.who.int/mediacentre/factsheets/fs339/en/)

Tran MT, Holdford DA, Kennedy DT, Small RE. Modeling the cost-effectiveness of a smoking-cessation program in a community pharmacy practice. Pharmacotherapy. 2002 Dec;22(12):1623-31. — View Citation

Vial RJ, Jones TE, Ruffin RE, Gilbert AL. Smoking cessation program using nicotine patches: linking hospital to the community. J Pharm Pract Res. 2002;32:57-62.

Zillich AJ, Ryan M, Adams A, Yeager B, Farris K. Effectiveness of a pharmacist-based smoking-cessation program and its impact on quality of life. Pharmacotherapy. 2002 Jun;22(6):759-65. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence Rate	To compare abstinence rates among participants who make a quit attempt, receiving either an intensive or abbreviated version of a pharmacist delivered smoking cessation program vs. those who receive usual care.	6 months
Secondary	Abstinence Rate	To compare abstinence rates among participants who make a quit attempt, receiving either an intensive or abbreviated version of a pharmacist delivered smoking cessation program vs. those who receive usual care.	3 months
Secondary	Quit Attempts	To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group.	3 months
Secondary	Quit Attempts	To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group.	6 months
Secondary	Change in baseline quality of life measured using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) survey	To compare the change in quality of life between each group.	0 and 6 months
Secondary	Change in baseline self-efficacy using a self efficacy survey	To compare the change in self-efficacy between each group.	0 and 6 months
Secondary	Satisfaction survey	A measure of the satisfaction of participants with receiving a pharmacist delivered smoking cessation program, or quitting using usual care.	6 months
Secondary	Cost-effectiveness using an estimate an incremental cost per quality adjusted life year (QALY) gained	To assess the cost-effectiveness of an intensive, and abbreviated, pharmacist delivered smoking cessation support program vs. usual care. The cost of delivering each service will be combined with the outcome of each to estimate an incremental cost per quality adjusted life year (QALY) gained.	6 months